The rising prices of various pharmaceutical drugs is a major topic of concern in the U.S. healthcare system. The impact of rising drug prices has been documented and reported in recent years. One impact includes the marketing of counterfeit drugs. Counterfeit drugs is an increasing problem given the ever increasing retail prices of various newly developed drugs. Further, it is difficult to detect whether a pharmaceutical substance is authentic or counterfeit without expensive laboratory equipment and extensive testing. A tablet manufactured from paste looks identical to an advanced cancer fighting drug. Similarly, water-based solutions look similar to sophisticated drugs in liquid form. Not surprisingly, various criminal elements are beginning to manufacture counterfeit drugs and introducing them into the supply chain to gain quick and huge profits.
In the U.S., marketing of drugs has been historically closely regulated. The regulation of the delivery of drugs from the manufacturer to the retailer makes it difficult to introduce counterfeit drugs. However, the supply chain has been recently impacted by the introduction of the Internet. Various web sites now offer drugs directly to consumers, and there is no guarantee of the quality or authenticity of the drugs. In fact, the ability of U.S. consumers to purchase drugs from Canada and other countries using the Internet, as well as by crossing the border, is an area of recent intense public debate. Lower costs of the identical drug in other countries has motivated U.S. consumers to use the Internet to purchase drugs from foreign pharmacies. Issues of public safety and drug quality are a concern to both the U.S. government and the drug manufacturers. Instances have been detected where counterfeit drugs were sold and passed off as legitimate life saving drugs, thus eroding public confidence in the drug delivery infrastructure.
Further, the globalization of trade often results in many drugs being manufactured in other countries and readily available in almost any part of the world. A drug manufacturing plant in a third world country may not have stringent quality and security controls, and drugs may be improperly imported and introduced into the U.S. supply chain as a genuine, domestic manufactured pharmaceuticals. Absent differences in the packaging, it can be difficult to distinguish genuine drugs from counterfeit drugs. Further, it is easy for counterfeiters to copy the packaging so that the average consumer cannot tell the difference between legitimate goods and counterfeit goods.
The ever increasing price of various pharmaceutical drugs, the increasing desire of consumers to obtain various drugs at lower prices, the ubiquitous offers for drugs promised at a lower cost over the Internet, the ease of which counterfeit pharmaceuticals can be smuggled into the U.S., all lead to the increasing problem of counterfeit drugs being introduced into the pharmaceutical supply chain.
Further complicating the picture is the possibility of terrorists deliberately causing massive public disruption in the U.S. healthcare system by attempting to introduce counterfeit drugs, not only for profit motive, but for terroristic motives. Past events where over-the-counter drugs were adulterated caused immense public concern (e.g., filling Tylenol tablets with cyanide). The introduction of counterfeit drugs would significantly weaken consumer confidence in legitimate and authentic drugs.
All these factors lead to the need for a system of tracking pharmaceuticals from the factory, along the supply chain, to the point of sale or dispensing, where the authenticity of the goods can be verified by various entities in the supply chain. Further, there is a need to indicate any condition that relates to the safety and purity of the drugs.